Effectiveness of Diacutaneous Fibrolysis in Painful Shoulder

Effectiveness of Diacutaneous Fibrolysis on Pain and Mobility in Patients Suffering From Painful Shoulder. A Randomized Pilot Study.

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00884065

Enrollment

Registered

2009-04-20

Start date

2007-06-30

Completion date

2008-01-31

Last updated

2015-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Shoulder Pain

Keywords

Physiotherapy, Manual therapy, Painful Shoulder, Diacutaneous Fibrolysis

Brief summary

While Diacutaneous fibrolysis (DF) has achieved promising results empirically, its effectiveness has not been tested in clinical trials. The investigators hypothesized that the use of DF in patients suffering from painful shoulder would increase the active mobility and reduce the pain during movement. To test the hypothesis a double blind (patient and investigator) randomized clinical trial was carried out in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session.

Detailed description

Background and objectives: Diacutaneous fibrolysis (DF) is a manual technique to treat the mechanical pain of the musculoskeletal system. While this technique has achieved promising results empirically, its effectiveness has not been tested in clinical trials. We aimed at evaluating the effectiveness of a single session of DF on pain and mobility in patients suffering from painful shoulder. Subjects and methods: This clinical trial took place in two public Primary Health Care Centres. Fifty patients were randomly allocated to two groups: the intervention group, who received a real DF session, and the control group, who received a placebo DF session. The degree of active mobility (flexion, abduction, extension, external and internal rotation), the pain in the hand behind back position and the participant's perception of the technique in terms of comfort and results obtained were measured.

Interventions

OTHERDiacutaneous Fibrolysis

The implementation of the technique consists of three consecutive stages: The first stage involves manual palpation, which is carried out by the hand that is not holding the hook, with the objective to find the area to be treated; the second, or instrumental palpation stage, is carried out by introducing the spatula of the hook together with the index finger of the palpatory hand to locate with precision the adherent connective fibers or fibrous corpuscles; the third, or fibrolysis stage, is the actual treatment. Here, a brief supplementary traction is carried out with the hook.

OTHERDiacutaneous Fibrolysis (placebo)

The placebo was designed for this study and the stages of manual and instrumental palpation occur strictly at a superficial level. In the third stage, instead of fibrolysis a pinch of skin is hold with the thumb of the palpatory hand and the tip of the spatula, so that the patient feels the hook distinctly but without any action taking place on the deep tissular planes.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* over 18 years of age * being referred for treatment of painful shoulder (except for adhesive capsulitis) * not having been previously treated with DF

Exclusion criteria

* Damaged skin and/or cutaneous lesions in the shoulder area * History of shoulder surgery * Vascular abnormalities * Platelet antiaggregant therapy * Acute inflammatory condition of the shoulder (\<1 week) * Patients with a pending litigation or court claim

Design outcomes

Primary

Measure	Time frame	Description
Change in Active Flexion Movement After Intervention Minus Baseline	Baseline and the same day (just after intervention)	A universal double armed goniometer was used to measure change in active flexión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
Change in Active Abduction Movement After Intervention Minus Baseline	Baseline and the same day (just after intervention)	A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination
Change in Active extensión Movement After Intervention Minus Baseline	Baseline and the same day (just after intervention)	A universal double armed goniometer was used to measure change in active extensión movement in the sagital plane with the elbow fully extended and the forearm in indifferent pronosupination (thumb forward)
Change in Active External Rotation After Intervention Minus Baseline	Baseline and the same day (just after intervention)	A universal double armed goniometer was used to measure change in active external rotation measured in the neutral position of the shoulder (arm pinned to the trunk), elbow flexed to 90º and the forearm in indifferent pronosupination (thumb forward)
Change in Active Internal Rotation After Intervention Minus Baseline	Baseline and the same day (just after intervention)	Change in active internal rotation was measured with the hand behind back test. The position achieved by the tip of the thumb was marked and with a flexible metric tape (always the same) the distance in centimetres between this mark and the inferior tip of the spinous process of C7 was measured; the shorter the distance, the better the mobility

Secondary

Measure	Time frame	Description
Change in Pain in the Hand Behind Back Position After Intervention Minus Baseline	Baseline and the same day (just after intervention)	An unmarked Visual Analogue Scale from 0 (no pain) to 100 (worst pain) millimeters was used. At baseline, participants registered the pain perceived in the position used to measure the internal rotation. After intervention, they registered the pain with the hand placed in the same position taking as a reference the mark in the first evaluation.

Countries

Spain

Participant flow

Recruitment details

The study participants were recruited from two public services of primary health care of the Spanish National Health Service, one in Cornellà de Llobregat (Barcelona), the other in Ponteareas (Pontevedra), from June 2007 to January 2008.

Participants by arm

Arm	Count
Intervention Group (Diacutaneous Fibrolysis) The intervention group was treated with a single session of Diacutaneous Fibrolysis following the standard procedure.	25
Control Group (Placebo) The control group was treated with a single placebo session of Diacutaneous Fibrolysis.	25
Total	50

Baseline characteristics

Characteristic	Intervention Group (Diacutaneous Fibrolysis)	Control Group (Placebo)	Total
Age, Categorical <=18 years	0 Participants	0 Participants	0.0 Participants
Age, Categorical >=65 years	8 Participants	10 Participants	18.0 Participants
Age, Categorical Between 18 and 65 years	17 Participants	15 Participants	32.0 Participants
Age, Continuous	56.76 years STANDARD_DEVIATION 10.33	60.8 years STANDARD_DEVIATION 10.12	58.78 years STANDARD_DEVIATION 10.33
Months of pain	14.48 Months STANDARD_DEVIATION 16.21	17.88 Months STANDARD_DEVIATION 27.56	16.18 Months STANDARD_DEVIATION 22.44
Region of Enrollment Spain	25 participants	25 participants	50.0 participants
Sex: Female, Male Female	16 Participants	13 Participants	29.0 Participants
Sex: Female, Male Male	9 Participants	12 Participants	21.0 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	— / —	— / —
other Total, other adverse events	0 / 25	0 / 25
serious Total, serious adverse events	0 / 25	0 / 25

Outcome results

Primary

Change in Active Abduction Movement After Intervention Minus Baseline

A universal double armed goniometer was used to measure change in active abduction movement in the scapular plane with the elbow in extension and the forearm in supination